Job Description- Supporting the client in all aspects of safety submission
- Supports the Submission Manager in development, documentation, implementation and maintenance of submission processes and standards
- Ensures personal knowledge and understanding of global regulatory reporting requirements to ensure compliance
- Performing submissions of ICSRs/aggregate reports to all concerned parties
- Performing exchanges of ICSRs with all concerned parties as per applicable documents
- Providing support in all PV operations associated with Safety Reporting
- Performing Quality control of ICSR Reportability Assessment
- Performing Quality control of daily safety submission activities
- Active participation in trainings, maintenance and development of quality system documents for Safety Reporting area
- Provide training for junior members of the team
- Acts as an SME for Submissions in audits and inspections representing Submissions business processes and standards
Qualifications- Life science graduate, pharmacy, nursing or other healthcare related qualification
- 3-5 years of work experience in pharmacovigilance with at least 2 years of experience working on submissions
- Organization skills, including attention to detail and multitasking
- Management skills, including time and issue management
- Communication skills, including clear and effective interaction with internal and external stakeholders
English - fluent (spoken, written)
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